Journal of affective disorders · 2026
Efficacy and safety of Dimdazenil in primary insomnia and depressive episodes/bipolar depressive episode with insomnia: A post-marketing, randomized, open-label, positive-controlled study.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Dun Wenwen, Wu Tingfang, Tian Lu, Sun Guangqiang, Yang Fan, Huang Juan, Hu Chen, Li Anning, Wang Gang
Аннотация
OBJECTIVES: To assess the efficacy and safety of Dimdazenil in primary insomnia and depressive episodes/bipolar depressive episode with insomnia.
METHODS: In this post-marketing, positive-controlled study, eligible patients were assigned 1:1 to receive either Dimdazenil 2.5 mg or Midazolam 15 mg (minimum 3 doses/week) over 14 days. The primary endpoint was the between-group difference in subjective total sleep time (sTST) on Day 14.
RESULTS: 185 patients were included (Dimdazenil, N = 93; Midazolam, N = 92). Dimdazenil significantly increased sTST from baseline (LSM difference, +113.33 min, P < 0.001), with a mean between-group difference of +7.36 min versus Midazolam. A higher proportion of patients in the Dimdazenil group achieved sTST≥390 min (59.49% vs. 48.72%) and sTST≥8 h (34.8% vs. 23.1%). Significant reductions from baseline were also observed in sSL and ISI (both P < 0.001). Daytime functioning was significantly improved with Dimdazenil, as evidenced by marked reductions in ESS, FFS, and TMT-A completion time (all P < 0.001). Moreover, FFS decreased more from baseline with Dimdazenil than Midazolam (-3.86 vs. -2.48). Descriptive improvements in sWASO, sNAW, and FFS scores were observed in patients with depressive episodes/bipolar depressive episode with insomnia. Most TEAEs in the Dimdazenil group were mild (89.66%, 26/29), with no severe TEAE or death reported.
CONCLUSIONS: In this exploratory study, Dimdazenil was associated with improvements in subjective sleep parameters and daytime functioning in patients with primary insomnia and depressive episodes/bipolar depressive episode with insomnia. Improvements in sleep maintenance outcomes and in patients with depressive episodes/bipolar depressive episode with insomnia warrant further investigation in adequately powered confirmatory studies.
CLINICAL TRIAL REGISTRATION: This study was registered on the Chinese Clinical Trial Registry (https://www.chictr.org.cn; registration number: ChiCTR2400085915).
METHODS: In this post-marketing, positive-controlled study, eligible patients were assigned 1:1 to receive either Dimdazenil 2.5 mg or Midazolam 15 mg (minimum 3 doses/week) over 14 days. The primary endpoint was the between-group difference in subjective total sleep time (sTST) on Day 14.
RESULTS: 185 patients were included (Dimdazenil, N = 93; Midazolam, N = 92). Dimdazenil significantly increased sTST from baseline (LSM difference, +113.33 min, P < 0.001), with a mean between-group difference of +7.36 min versus Midazolam. A higher proportion of patients in the Dimdazenil group achieved sTST≥390 min (59.49% vs. 48.72%) and sTST≥8 h (34.8% vs. 23.1%). Significant reductions from baseline were also observed in sSL and ISI (both P < 0.001). Daytime functioning was significantly improved with Dimdazenil, as evidenced by marked reductions in ESS, FFS, and TMT-A completion time (all P < 0.001). Moreover, FFS decreased more from baseline with Dimdazenil than Midazolam (-3.86 vs. -2.48). Descriptive improvements in sWASO, sNAW, and FFS scores were observed in patients with depressive episodes/bipolar depressive episode with insomnia. Most TEAEs in the Dimdazenil group were mild (89.66%, 26/29), with no severe TEAE or death reported.
CONCLUSIONS: In this exploratory study, Dimdazenil was associated with improvements in subjective sleep parameters and daytime functioning in patients with primary insomnia and depressive episodes/bipolar depressive episode with insomnia. Improvements in sleep maintenance outcomes and in patients with depressive episodes/bipolar depressive episode with insomnia warrant further investigation in adequately powered confirmatory studies.
CLINICAL TRIAL REGISTRATION: This study was registered on the Chinese Clinical Trial Registry (https://www.chictr.org.cn; registration number: ChiCTR2400085915).